基于FMEA的伽玛刀治疗计划质量改进

Quality improvements of gamma knife treatment plan based on FMEA

目的 :运用先进的质控工具,前瞻性地对伽玛刀治疗计划设计的风险进行分析、评价,对关键事件进行改进。方法 :由物理师、医师与技师组成的质量改进小组采用失效模式与效应分析(failure mode and effect analysis,FMEA),对200份伽玛刀治疗计划与100例计划设计过程进行失效风险评价,运用因果法与故障树法分析失效原因,找出改进对策。结果:对风险较高的9个失效模式、16个失效原因进行改进后,风险值明显降低,平均下降(61.125±8.125)%。结论:FMEA是改进伽玛刀治疗计划设计质量的有效工具,有助于减少潜在风险的发生。

Objective：By using the advanced quality control tools,we analyzed and evaluated the risk of planning designs of gamma knife treatment prospectively,and improved the key events. Methods：A quality reconstruction team of physicists,oncologists and therapists conducted failure risk assessment analysis toward 200 gamma knife treatment plans and 100 treatment designs were performed by using failure mode and effect analysis（FEMA）,and failure cause and countermeasures were analyzed by using causal factor analysis and fault tree analysis. Results：The risk priority number was significantly decreased [average of（61.125 ± 8.125）% ]after conducting improvement on 9 potential failure modes and 16 potential causes of failure. Conclusion：FMEA is a effective tool to improve the quality of gamma knife treatment planning designs. It helps reduce the potential risks as well.